Affimed N.V. (NASDAQ:AFMD) Q4 2023 Earnings Call Transcript

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Daina Graybosch: Okay. Thank you very much.

Operator: Thank you. Please stand-by for our next question. Our next question comes from the line of Maury Raycroft with Jefferies. Your line is open.

Unidentified Analyst: Hi. This is Kevin on for Maury. Thanks for taking our questions. Just the first one, just a follow-up on AFM13, could you characterize the experience you’re seeing so far with this trial and whether it’s similar to the MD Anderson experience particularly with respect to safety and efficacy? And then for the data updates in the second quarter especially for the AFM24 update, are you just – are you saying whether that’s going to be at ASCO or potentially a company event? Thanks.

Andreas Harstrick: Yes. So for the first question, as we have guided we will give the first update both on safety and efficacy in Q2 when we have a meaningful number of patients. So today, I can only comment on the recruitment, and this I think we addressed already. For the AFM24 study, we have not finally decided what’s the right or the venue will be. As you know, ASCO will notify on the program over the next couple of days and this will guide our programs or our plans, how and when to disclose and which forum to disclose this data.

Unidentified Analyst: Great. Thanks. And just one more on AFM28, it seems like the focus here is potentially on the combination. Can you talk about when you could potentially start that? And if you’re talking with potential partners here for Allogeneic NK’s?

Andreas Harstrick: Yes. Yes, you are right. We believe that the main focus, if you look at the biology of AML will be also development in combination with an Allogeneic NK cell. And as I said during my talk, we will provide an update in Q2 including a detailed plan how to move forward.

Unidentified Analyst: Great. Thanks.

Operator: Thank you. [Operator Instructions] Our next question comes from the line of Yanan Zhu with Wells Fargo. Your line is open.

Unidentified Analyst: Hi. Thanks for taking our question. This is Quan Han [ph] for Yanan. So you mentioned the – sorry, it’s for AFM13. You mentioned the enrollment in Cohorts 1 and 2 are slower than expected due to staggering and patient dropout. I wonder if you can share any colors on the patients who drop out and what’s the rate of dropout? Thank you.

Andreas Harstrick: Yes. So the reasons for dropout were very heterogeneous and as it happened during the screen period, obviously not related to any treatment. One of the patients, for example, who was already about 2.5 weeks in the screening period, acquired COVID infection. We then waited for the COVID infection to clear. However, this patient – this was an elderly patient had a remaining or residual impairment in his lung function. So this was one of the reasons for dropout. We had a second patient who acquired a CMV infection again, not clearing and then dropping out of it. So it’s only a few patients, but again as you can only assign one cohort at or one slot at a certain period in time. This always will delay the refilling of the next slot by three to four weeks.

Again, we are through the staggering period now. Now we can recruit in parallel, and we see good recruitment, which gives us confidence that by Q2, we will report data on the 12 patients from Cohort 1 and 2 and then a certain number of patients from Cohorts 3 and 4.

Unidentified Analyst: Got it. That’s very clear. Thank you. And any color on the safety you have seen so far? Is there any difference compared to what you have seen in your NDA study? Thank you.

Andreas Harstrick: Again, we will provide more detailed safety update in Q2. However, we are very confident with the progression through the SRC. So we have not encountered any dose-limiting toxicities or anything like that.

Unidentified Analyst: Got it. Thank you so much for the colour.

Operator: Thank you. Ladies and gentlemen that concludes our Q&A portion for today. Thank you for your participation in today’s conference call. You may now disconnect. Everyone, have a wonderful day.

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